Method and device for distending a gynecological cavity

• US 9,259,233 B2
• Filed: 12/06/2007
• Issued: 02/16/2016
• Est. Priority Date: 04/06/2007
• Status: Active Grant

• Current Assignee: Hologic Incorporated
• Original Assignee: Hologic Incorporated
• Inventors: Gruber, William H., Adams, Ronald D., Lorenz, Michael A., Crisp, Ryan S., Clcenas, Chris W., Burchfield, Brent L., DiCesare, Paul, Radziunas, Jeffrey, Vigliotti, Daniel
• Primary Examiner(s): Shi, Katherine M
• Assistant Examiner(s): MENDOZA, MICHAEL G
• Application Number:
  US11/951,853
• Publication Number:
  US 20080249534A1
• Time in Patent Office: 2,994 Days
• Field of Search: 606191-193, 606/198, 600201-204
• US Class Current: 1/1
• CPC Class Codes: A61B 1/0615 for radial illumination
• CPC Class Codes: A61B 1/0661 Endoscope light sources
• CPC Class Codes: A61B 1/303 for the vagina, i.e. vaginoscopes
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 17/4241 Instruments for manoeuvring or retracting the uterus, e.g. during laparoscopic surgery
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00862 elastic or resilient
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/00893 : pharmaceutically effective
• CPC Class Codes: A61B 2017/12018 : Elastic band ligators
• CPC Class Codes: A61B 2017/12127 : Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61B 2017/22038 : with a guide wire
• CPC Class Codes: A61B 2017/306 : holding by means of suction
• CPC Class Codes: A61B 2017/32007 : with suction or vacuum means
• CPC Class Codes: A61B 2017/320071 : with articulating means for working tip
• CPC Class Codes: A61B 2090/064 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/306 : using optical fibres
• CPC Class Codes: A61B 5/6875 : Uterus
• CPC Class Codes: A61F 6/20 : Vas deferens occluders; Fallopian occluders
• CPC Class Codes: A61F 6/225 : transcervical
• CPC Class Codes: A61M 2025/1047 : having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/105 : having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/0026 : Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/09 : Guide wires
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 31/002 : Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 37/0092 : using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61N 5/0603 : for treatment of body cavities
• CPC Class Codes: A61N 5/062 : Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: A61N 7/022 : intracavitary

Abstract

Method and device for distending a gynecological cavity. According to one embodiment, a mechanical, non-fluid device is used to distend the gynecological cavity. Such devices include, for example, self-expanding members, such as resilient baskets, coils, whisks, prongs, and loops, or mechanically expanded members, such as inflatable balloons, mechanically-expanded cages and loops, and scissor jacks. The device may serve a purpose in addition to distension, such as illumination, imaging, irrigation, drug delivery, resection and cauterization.

Claims

1. A method of performing a transcervical surgical procedure in a uterus, comprising:

transcervically positioning an expandable support structure within the uterus using a deployment tool releasably attached to the support structure;

expanding the support structure into a three-dimensional configuration including an upper portion and a lower portion spaced apart from the upper portion, wherein expanding the support structure delivers an expansion force against opposing walls of the uterus to thereby create a three-dimensional void within the uterus between the upper and lower portions of the expanded support structure through non-fluid mechanical distention of the uterus;

detaching the deployment tool from the expanded support structure;

removing the deployment tool from the uterus, leaving the expanded support structure in place;

after removal of the deployment tool from the uterus, introducing a surgical instrument into the uterus so that a distal end of the surgical instrument is located in the void between the upper and lower portions of the expanded support structure;

using the surgical instrument to perform a surgical procedure in the uterus by advancing the surgical instrument through an opening in the expanded support structure while the expanded support structure distends the uterus through non-fluid mechanical distention, the surgical procedure including removal of uterine wall tissue through the opening;

removing the surgical instrument from the uterus upon completion of the surgical procedure,

collapsing the support structure within the uterus after removal of the surgical instrument from the uterus; and

removing the collapsed support structure from the uterus.

2. The method as in claim 1, further comprising coupling the support structure to a removal tool before collapsing and removing the support structure from the uterus.

3. The method as in claim 1, wherein the procedure is surgical removal of fibroid tissue.

4. The method as in claim 1, wherein expanding the support structure delivers an expansion force of at least about 0.5 lbs to mechanically distend the uterus.

5. The method as in claim 1, wherein expanding the support structure delivers an expansion force of at least about 1.0 lbs to mechanically distend the uterus.

6. The method as in claim 1, wherein expanding the support structure delivers an expansion force of at least about 5.0 lbs to mechanically distend the uterus.

7. The method as in claim 1, wherein expanding the support structure achieves an equivalent distension of the uterus to that achieved by introduction of a liquid distension media at a pressure of at least about 40 mm Hg.

8. The method as in claim 1, wherein expanding the support structure achieves an equivalent distension of the uterus to that achieved by introduction of a liquid distension media at a pressure of about 70 mm Hg.

9. The method as in claim 1, the uterus having a fundus, wherein the expanded support structure contacts a surface of the fundus.

10. A method of performing a procedure in a uterus of a patient, the uterus having a cervix at a proximal end and a fundus at a distal end, comprising:

positioning a deployment tool in at least inside the cervix;

delivering an expandable support structure through the deployment tool and into the uterus;

expanding the support structure into a three-dimensional configuration including an upper portion and a lower portion spaced apart from the upper portion, wherein expanding the support structure delivers an expansion force against opposing walls of the uterus to thereby create a three-dimensional void within the uterus between the upper and lower portions of the expanded support structure through non-fluid mechanical distention of the uterus;

removing the deployment tool from inside the patient, leaving the expanded support structure in place within the uterus;

after removal of the deployment tool from the patient, introducing a surgical instrument into the uterus so that a distal end of the surgical instrument is located in the void between the upper and lower portions of the expanded support structure;

using the surgical instrument to perform a surgical procedure in the uterus by advancing the surgical instrument through an opening in the expanded support structure while the expanded support distends the uterus through non-fluid mechanical distention, the surgical procedure including removal of uterine wall tissue through the opening;

removing the surgical instrument from the uterus upon completion of the surgical procedure,

collapsing the support structure within the uterus after removal of the surgical instrument from the uterus; and

removing the collapsed support structure from the uterus.

11. The method as in claim 10, the uterus having a fundus, wherein the expanded support structure contacts a surface of the fundus.

12. The method as in claim 10, further comprising coupling the expandable support structure to a removal tool before removing the expandable support structure from the uterus.

13. The method as in claim 10, wherein the procedure is surgical removal of fibroid tissue.

14. A method of performing a transcervical procedure in a uterus of a patient, comprising:

transcervically positioning an expandable support structure within the uterus using a deployment tool that is inserted into the patient to access the uterus, the deployment tool being releasably attached to the support structure, the support structure comprising a three-dimensional array of filaments, with adjacent filaments of the array defining windows there between;

expanding the support structure, wherein expanding the support structure delivers an expansion force against opposing walls of the uterus so that the expanded filament array defines a three-dimensional interior void within the uterus through non-fluid mechanical distention of the uterus, thereby providing access to uterine wall tissue from within the interior void of the expanded support structure through the windows of the expanded support structure;

detaching the deployment tool from the expanded support structure;

removing the deployment tool from the patient, while leaving the expanded support structure in the patient'"'"'s uterus;

after removing the deployment tool from the patient, introducing a surgical instrument into the uterus so that a distal end of the surgical instrument is located in the interior void of the expandable support structure defined by the filament array; and

using the surgical instrument to remove uterine wall tissue through one or more windows defined by adjacent filaments of the expanded support structure while the support structure distends the uterus through non-fluid mechanical distention.

15. The method as in claim 14, further comprising coupling the support structure to a removal tool, and removing the support structure from the uterus.

16. The method as in claim 14, wherein the uterine wall tissue comprises fibroid tissue.

17. The method as in claim 14, wherein expanding the support structure delivers an expansion force of at least about 5.0 lbs to mechanically distend the uterus.

18. The method as in claim 14, wherein expanding the support structure achieves an equivalent distension of the uterus to that achieved by introduction of a liquid distension media at a pressure of at least about 40 mm Hg.

19. The method as in claim 14, the uterus having a fundus, wherein the expanded support structure contacts a surface of the fundus.